Uncontrolled Type 2 Diabetes MellitusNCT07598071
A Comparison of Single-Stage Full-Mouth Disinfection With Quadrant-Based Scaling and Root Planing in Patients With Uncontrolled Type 2 Diabetes and Severe Periodontitis: An Assessment of Its Impact on Quality of Life
A study testing Quadrant based scaling and root planning and full mouth disinfeciton in people with Uncontrolled Type 2 Diabetes Mellitus and Severe Periodontitis, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the effects of a single-stage full mouth disinfection (FMD) protocol versus a quadrant-based tooth surface cleaning and root planing (Q-SRP) protocol on changes in clinical periodontal parameters over a 3-month period, as well as on the social, psychological and functional well-being of patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uncontrolled Type 2 Diabetes Mellitus, Severe Periodontitis
- What is being tested?
- Quadrant based scaling and root planning and full mouth disinfeciton
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Nov 2024to 3 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with poorly controlled diabetes and HbA1c levels between 7% and 9%
- At least 15 natural teeth and, from a periodontal perspective: probing pocket depth (PPD) ≥ 6 mm, clinical attachment loss (CAL) ≥ 5 mm, radiographic bone loss extending to the middle or apical third of the root, and periodontitis-related tooth loss of ≤ 4 in different quadrants
Who cannot join
- Individuals who were pregnant or breastfeeding
- Patients with a history of acute or chronic infection within the past 6 months
- Patients who had undergone periodontal treatment within the past 6 months
- Patients receiving systemic antibiotic therapy during the same period
- Patients using non-steroidal anti-inflammatory drugs, phenytoin, calcium channel blockers or cyclosporine
- Patients undergoing hormone therapy
Show all 9Show fewer
- Individuals who had used antibiotics or anti-inflammatory drugs regularly during the 3-month period following the start of the study
- İndividuals with medical or psychological conditions that could affect the accurate understanding and completion of the questionnaires
- Smokers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Pamukkale, 20160
About this study
This study evaluated the effects of a single-stage full mouth disinfection (FMD) protocol versus a quadrant-based tooth surface cleaning and root planing (Q-SRP) protocol on changes in clinical periodontal parameters over a 3-month period, as well as on the social, psychological and functional well-being of patients with poorly controlled type 2 diabetes and severe periodontitis.
Read the detailed description
In this study, Q-SRP was administered to one group of patients with uncontrolled diabetes and severe periodontitis, whilst the TAD protocol was implemented in the other group. All clinical procedures were carried out in accordance with standard protocols. Post-treatment assessments were carried out at the 1-month and 3-month follow-up periods; all clinical periodontal measurements recorded at baseline, along with the OHIP-14 and OIDP questionnaires, were repeated in the same manner. This enabled a comparative analysis of the efficacy of the treatment methods applied and the clinical changes over time.
- Being tested
- Quadrant based scaling and root planning, full mouth disinfeciton
- Keywords
- full mouth disinfection, quadrant based scaling and root plannig
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadrant based scaling and root planningProcedure or surgery
Also called Q-SRP
Quadrant-Based Treatment treats one quadrants at a time over four weeks
full mouth disinfecitonProcedure or surgery
Also called FMD
Full Mouth Disinfection involves scaling and root planing all teeth within 24 hours, often paired with intensive antiseptics to prevent re-infection from remaining pockets
| Study group | Role | What they receive |
|---|---|---|
| Quadrant based scaling and root plannig | Active comparator | Quadrant based scaling and root plannig Receives: Procedure: Quadrant based scaling and root planning |
| Full mouth disinfection | Experimental | Full mouth disinfection Receives: Procedure: full mouth disinfeciton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaires
The impact of periodontal treatments on patients' quality of life was investigated by administering the OHIP-14 and OIDP questionnaires at baseline, one month post-treatment, and three months post-treatment. Responses obtained from participants via the OHIP-14 questionnaire were assessed using a five-point Likert scale for each item. The scale was scored as follows: 0 (never), 1 (rarely), 2 (occasionally), 3 (often) and 4 (very often). The total oral health-related quality of life score for each individual was calculated by summing the scores given for each question.
Measured: Before treatment, 1 and 3 months after treatment
Secondary outcomes (7)
Percentage of Deep (≥ 7 mm) Probed Pockets
During measurements taken using a Williams periodontal probe (Hu Friedy, Chicago, Illinois, USA), the probe was positioned parallel to the long axis of the teeth without applying pressure, and the distance from the gingival margin to the base of the periodontal pocket was measured and recorded. The percentage of pocket depths of 7 mm or more, measured from the six regions of each tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual), was calculated relative to the total number of tooth surfaces measured in the mouth. The percentage of all pocket depths of 7 mm or more in the individual's mouth was calculated using the following formula.
% ≥ 7 mm PD = Total of pocket depths of 7 mm or more × 100 / Total number of teeth × 6
Measured: Before treatment, month after treatment and 3 months after treatment
Percentage of Pockets Detected at Medium Depth (4-6 mm)
During measurements taken using a Williams periodontal probe (Hu Friedy, Chicago, Illinois, USA), the probe was positioned parallel to the long axis of the teeth without applying pressure, and the distance from the gingival margin to the base of the periodontal pocket was measured and recorded. The percentage of pocket depths within the 4-6 mm range, measured from six regions of each tooth (mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual), was calculated relative to the total number of tooth surfaces measured in the mouth. The percentage of pocket depths within the 4-6 mm range for the entire mouth was calculated using the following formula.
%4-6 mm PD = (Total of 4-6 mm pocket depths × 100) / (Total number of teeth × 6)
Measured: Before treatment, month after treatment and 3 months after treatment
Clinical Attachment Level
The distance from the enamel-cementum junction to the sulcus/pocket floor was measured in millimetres on six surfaces of the tooth-mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual-using a Williams periodontal probe (Williams periodontal probe, Hu Friedy, Chicago, IL, USA). The average CAL value for the entire mouth was calculated using the following formula:
CAL = Sum of clinical attachment levels / Number of existing teeth × 6
Measured: Before treatment, month after treatment and 3 months after treatment
Probed Pocket Depth
Pocket depth was measured in six regions: mesiobuccal, buccal, distobuccal, mesiolingual, lingual and distolingual. A Williams periodontal probe was used for the measurements (Hu Friedy, Chicago, Illinois, USA).
During the measurements, the periodontal probe was positioned parallel to the long axis of the teeth without applying pressure, and the distance from the gingival margin to the base of the periodontal pocket was measured and recorded. The following formula was used to determine the average PD for the individual's entire mouth.
PD = Sum of probed pocket depths / Number of existing teeth × 6
Measured: Before treatment, month after treatment and 3 months after treatment
Bleeding on Probing
When the periodontal probe was gently moved along the gingival sulcus, a score of (+) was assigned if bleeding occurred, and (-) if no bleeding occurred. The final score was calculated as a percentage (%).
Bleeding Score (%) = Number of teeth with bleeding × 100 / Total number of teeth
Measured: Before treatment, month after treatment and 3 months after treatment
Plaque Index
The Silness-Löe plaque index (PI) was used to measure the degree of plaque formation and accumulation in the mouth. According to this index:
0 = No bacterial plaque in the gingival region,
- = The presence of plaque that is not visible to the naked eye at the free gingival margin but can be detected by moving the probe through the gingival sulcus,
- = The presence of moderate plaque within the gingival pocket and on the tooth surface adjacent to the gingival margin,
- = The presence of a visible amount of dense, soft deposit within the gingival pocket and on the tooth surface adjacent to the gingival margin.
The individual's PI score was calculated using the following formula after summing the PI scores obtained from the mesiobuccal, buccal, distobuccal and lingual surfaces of each tooth.
PI = Total of PI scores for all teeth / Number of teeth present × 4
Measured: Before treatment, month after treatment and 3 months after treatment
Gingival Index
The Löe-Silness gingival index (GI) was used to diagnose gingival inflammation. According to this classification:
0=Healthy gums
- = Mild inflammation: Mild discolouration and mild swelling present, but no bleeding on probing
- = Moderate inflammation: Redness, swelling, glossiness and bleeding on probing
- = Severe inflammation: Marked redness and swelling. Ulcerations and a tendency towards spontaneous bleeding are present.
The individual's GI score was calculated using the following formula after summing the GI scores obtained from the mesiobuccal, buccal, distobuccal and lingual surfaces of each tooth.
GI = Total of GI scores for all teeth / Number of existing teeth × 4
Measured: Before treatment, month after treatment and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start13 Nov 2024
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uncontrolled Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine Ece Barlay, Pamukkale University
- Investigators
- Gizem Torumtay Cin, Assoc. Prof., Study director, Pamukkale University, Faculty of Dentistry, Department of PeriodontologyEmine Ece Barlay, Principal investigator, Pamukkale University Faculty of Dentistry, Department of Periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598071
- Sponsor's protocol ID
- E-60116787-020-601323
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Single-Stage Full-Mouth Disinfection With Quadrant-Based Scaling and Root Planing in Patients With Uncontrolled Type 2 Diabetes and Severe Periodontitis: An Assessment of Its Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT07598071
- Acronym / sponsor ID
- E-60116787-020-601323
- Keywords
- full mouth disinfection, quadrant based scaling and root plannig
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the effects of a single-stage full mouth disinfection (FMD) protocol versus a quadrant-based tooth surface cleaning and root planing (Q-SRP) protocol on changes in clinical periodontal parameters over a 3-month period, as well as on the social, psychological and functional well-being of patients with poorly controlled type 2 diabetes and severe periodontitis.
Detailed description
In this study, Q-SRP was administered to one group of patients with uncontrolled diabetes and severe periodontitis, whilst the TAD protocol was implemented in the other group. All clinical procedures were carried out in accordance with standard protocols. Post-treatment assessments were carried out at the 1-month and 3-month follow-up periods; all clinical periodontal measurements recorded at baseline, along with the OHIP-14 and OIDP questionnaires, were repeated in the same manner. This enabled a comparative analysis of the efficacy of the treatment methods applied and the clinical changes over time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadrant based scaling and root plannig | Active comparator | Procedure: Quadrant based scaling and root planningQuadrant based scaling and root plannig |
| Full mouth disinfection | Experimental | Procedure: full mouth disinfecitonFull mouth disinfection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals with poorly controlled diabetes and HbA1c levels between 7% and 9%
- At least 15 natural teeth and, from a periodontal perspective: probing pocket depth (PPD) ≥ 6 mm, clinical attachment loss (CAL) ≥ 5 mm, radiographic bone loss extending to the middle or apical third of the root, and periodontitis-related tooth loss of ≤ 4 in different quadrants
Key exclusion criteria (9 listed)
- Individuals who were pregnant or breastfeeding
- Patients with a history of acute or chronic infection within the past 6 months
- Patients who had undergone periodontal treatment within the past 6 months
- Patients receiving systemic antibiotic therapy during the same period
- Patients using non-steroidal anti-inflammatory drugs, phenytoin, calcium channel blockers or cyclosporine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadrant based scaling and root planningAlso: Q-SRPQuadrant-Based Treatment treats one quadrants at a time over four weeks | Procedure or surgery | Quadrant based scaling and root plannig |
| full mouth disinfecitonAlso: FMDFull Mouth Disinfection involves scaling and root planing all teeth within 24 hours, often paired with intensive antiseptics to prevent re-infection from remaining pockets | Procedure or surgery | Full mouth disinfection |
Primary outcome
Quality of life questionnaires
Time frame: Before treatment, 1 and 3 months after treatment
The impact of periodontal treatments on patients' quality of life was investigated by administering the OHIP-14 and OIDP questionnaires at baseline, one month post-treatment, and three months post-treatment. Responses obtained from participants via the OHIP-14 questionnaire were assessed using a five-point Likert scale for each item. The scale was scored as follows: 0 (never), 1 (rarely), 2 (occasionally), 3 (often) and 4 (very often). The total oral health-related quality of life score for each individual was calculated by summing the scores given for each question.
7 secondary outcomes
Percentage of Deep (≥ 7 mm) Probed Pockets
Time frame: Before treatment, month after treatment and 3 months after treatment
Percentage of Pockets Detected at Medium Depth (4-6 mm)
Time frame: Before treatment, month after treatment and 3 months after treatment
Clinical Attachment Level
Time frame: Before treatment, month after treatment and 3 months after treatment
Probed Pocket Depth
Time frame: Before treatment, month after treatment and 3 months after treatment
Bleeding on Probing
Time frame: Before treatment, month after treatment and 3 months after treatment
Plaque Index
Time frame: Before treatment, month after treatment and 3 months after treatment
Gingival Index
Time frame: Before treatment, month after treatment and 3 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Torumtay Cin, Assoc. Prof. study director
Pamukkale University, Faculty of Dentistry, Department of Periodontology
Emine Ece Barlay principal investigator
Pamukkale University Faculty of Dentistry, Department of Periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadrant based scaling and root planning and full mouth disinfeciton in people with Uncontrolled Type 2 Diabetes Mellitus and Severe Periodontitis, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life questionnaires (time frame: Before treatment, 1 and 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.